AstraZeneca Releases “Pooled Analysis” Phase 3 Data on COVID-19 Vaccine

AstraZeneca (AZ) and the University of Oxford have presented new data from a “pooled analysis” of phase 3 trials evaluating COVID-19 vaccine AZD1222 at two different dose regimens, demonstrating an average efficacy of 70.4 percent.

“We have begun submitting data to regulatory authorities around the world for early approval and our global supply chains are up and running, ready to quickly begin delivering hundreds of millions of doses on a global scale at no profit,” AZ CEO Pascal Soriot said.

Published in peer-reviewed The Lancet, trial results came from 11,636 trial participants in the UK and Brazil, featuring three different study arms. This includes two groups who received a two-dose regimen as well as the UK group, which received a one-and-a-half dose vaccination.

Serious concerns have been raised because the one-and-a-half dose regimen — reportedly first tested in the trial by accident — was found to be significantly more effective than the double-dose (DID, Dec. 4). According to ClinicalTrials.gov, the one-and-a-half dose regimen showed 90 percent efficacy, while the double-dose showed only 62 percent efficacy.

The pooled analysis states overall vaccine efficacy — calculated by averaging data from the two dose and one-and-a-half dose regimens — was shown to be 70.4 percent effective “at least 14 days” following the second injection. The University of Oxford claims no vaccinated participants were hospitalized or suffered serious forms of the disease. Most enrollees were aged 18 to 55, with those 56 or older comprising 12 percent of volunteers.

Follow-up safety data indicated that three of the 175 trial participants who reported serious adverse events had side effects deemed possibly related to treatment. One was a case of transverse myelitis, an inflammation of the spinal cord, another was a case of fever exceeding 100 degrees Fahrenheit, and the third case was haemolytic anaemia, which occurred in the control arm. The discovery of two additional cases of transverse myelitis, deemed unlikely to be related to the trial, led to a temporary pause in the study, and all participants recovered.

“We have known for many years that adenoviral-vectored vaccines fulfill the requirements for use against outbreak or pandemic diseases,” said investigator Dr. Sarah Gilbert from the University of Oxford. “They are safe, highly immunogenic, can be manufactured in large quantities at low cost and do not require frozen storage.”

See the data published in The Lancet: www.fdanews.com/12-08-20-vaccineefficacy.pdf. ― Jason Scott